The ICH Good Clinical Practice (GCP) guideline has been updated, and the transition from version R2 to R3 brings significant changes for clinical research professionals. To help you stay compliant and implement these updates effectively, GCP Central has launched the ICH GCP R2 to R3 Transition Course, a self-paced, interactive training designed for sponsors, investigators, and service providers such as CROs.
GET YOUR ICH GCP (E6) R3 TRANSITION TRAINING HERE
Why the R3 Update Matters
Finalized in January 2025, the ICH GCP E6 R3 guideline introduces critical revisions in areas such as principles and scope, responsibilities, data governance, and clinical trial setup. The European Medicines Agency (EMA) has announced that ICH GCP E6 R3 will be adopted on July 23, 2025, with ICH GCP E6 R2 remaining in effect until July 22, 2025.
More information on transition timelines here
What Our ICH GCP R3 Transition Training Covers
Our ICH GCP R3 Transition Course provides a structured approach to understanding the key changes, including:
- The revised principles and ethical considerations, including updates to the Declaration of Helsinki 2024
- The new focus on fit-for-purpose trial designs, proportionality, and quality by design
- Enhanced responsibilities and oversight for sponsors, investigators, and service providers
- Updated definitions and requirements for metadata, data acquisition tools, and digital data collection
- Changes to essential records, including updates to the Investigator’s Brochure (IB), Protocol, and Essential Records
- A breakdown of ICH GCP E6 R3 guidelines, including key ICH GCP R3 changes and the summary
A Flexible and Effective Learning Experience
This self-paced online course consists of six interactive modules, covering the entire clinical trial process from design to close-out. The course structure allows flexible learning, with chapters limited to 15-minute sessions for efficiency.
- Online exam and certification upon completion
- Easy access on desktop, tablet, and mobile
- Expert insights and practical applications
- One-year access for continuous learning and regulatory updates
Stay Ahead of Regulatory Changes
The ICH GCP R3 Transition Course ensures that professionals working in pharmaceutical and biotech companies, CROs, and investigator sites are fully prepared for the transition. This training provides ICH GCP certification and ensures compliance with the latest ICH GCP guidelines.
With ICH GCP E6 R3 coming into effect in 2025, now is the time to start updating your knowledge and integrating these changes into your clinical research practices. The course also complements our existing ICH GCP for Sponsors and ICH GCP for Investigators courses, which meet TransCelerate Biopharma’s mutual recognition requirements.
Get started today. Purchase the training here or, for teams of five or more, request a quote here.
